Medical Device Software Recall via Key Server Authentication
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Solution Overview
Problem
Existing Digital Rights Management (DRM) solutions are inadequate for managing complex content integrated from multiple third-party providers in medical devices, lacking the ability to track and recall software components independently of hardware recalls, ensuring payment for intellectual property, and maintaining security and confidentiality.
Innovation Solution
A medical device rights and recall management system using a key server to authenticate software and services, enabling tracking, managing, and recalling software components without physical device recall, while ensuring payment to content authors and maintaining security through a network-based service that registers and authenticates coding keys embedded in medical devices, service providers, or end-user computers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing DRM solutions are used to protect content, then the rights of singular content providers are protected, but the system cannot manage complex content integrated from multiple third-party providers
Solution Approach 1:
The patent segments the DRM system into multiple independent components: a key server for authentication, content servers for distribution, and device-specific modules. Each component handles specific tasks, allowing the system to manage content from multiple providers while maintaining security. The segmentation enables independent management of different content providers' rights and credentials.
Solution Approach 2:
The patent introduces a key server as an intermediary that mediates between content providers, service providers, and end-user devices. This intermediary authenticates credentials, manages digital rights, and coordinates recalls across the distributed system. The key server acts as a central authority that enables multi-provider content management while maintaining security and control.
2Reliability
If hardware recall is performed for software failures, then device quality is ensured, but the recall process is inefficient and costly
Solution Approach 1:
The patent extracts the software component management from the physical hardware device. By implementing DRM and recall capabilities at the software/license level rather than requiring physical device returns, the system can remotely disable or update software components. This separation allows quality control without the inefficiencies of physical recalls.
Solution Approach 2:
The patent replaces the mechanical/physical recall process with an electronic/digital system. Instead of physically retrieving devices from patients, the system uses electronic credentials and remote authentication to disable or update software components. This substitution dramatically improves recall efficiency while maintaining quality control.
3Ease of operation
If third-party service providers distribute content, then content accessibility is improved, but tracking and managing digital rights becomes complex
Solution Approach 1:
The patent implements a universal key server that serves multiple functions: authentication, credential verification, recall coordination, and rights management. This single universal system handles all third-party content providers uniformly, simplifying rights management despite the complexity of multiple providers and distribution channels.
4Ease of operation
If software components are distributed through multiple service providers, then content availability is improved, but ensuring payment to content authors becomes difficult
Solution Approach 1:
The patent implements a feedback mechanism where the key server tracks and records all content distribution transactions. Each time content is accessed or distributed through any service provider, the system records the transaction and ensures appropriate compensation to content authors. This feedback loop maintains payment integrity across multiple distribution channels.
Data Source
AI summary
The embodiments provide systems and methods for medical device rights and recall management system. A digital IP rights and recall management device activates a central key server to authenticate software contents and services operated on a microprocessor based medical devices through a coding key that may be embedded in a medical device or in a service provider server or in an end user computer. The recall management server unlocks the software content transmitted from or to a value-added service provider and selectively recall the value-added software component without requiring any physical recall of the medical device. The system maintains a virtual device master record which enables quality control and recall capability for software elements independent of any physical hardware recall.